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NCT03450109 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess LY01005 Versus Goserelin Comparator (ZOLADEX®) in Patients With Prostate Cancer
A Phase 1 study, sponsored by Luye Pharma Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT03450109: Completed Phase 1 study, sponsored by Luye Pharma Group.
NCT03450109 is a Phase 1 study that has completed, run by Luye Pharma Group. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03450109, a Phase 1 study, has completed, sponsored by Luye Pharma Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
A phase I, randomized, open-label and active-control study to assess the PK, PD and safety profiles of LY01005 versus goserelin comparator to be conducted in the USA.
Primary Outcome
Area under the concentration-time curve (AUC) Assessment Area under the concentration-time curve (AUC) for the Pharmacokinetics (PK) of gosereling from LY01005 and goserelin from Zoladex will be determined.
Interventions
- DRUG Zoladex
- DRUG LY01005
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2017-12-22 |
| Est. Completion | 2018-10-30 |
| Phase | Phase 1 |
What the finished NCT03450109 record still lists
NCT03450109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Zoladex is the first listed.
NCT03450109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03450109 about?
NCT03450109 is a clinical study titled "A Study to Assess LY01005 Versus Goserelin Comparator (ZOLADEX®) in Patients With Prostate Cancer". A phase I, randomized, open-label and active-control study to assess the PK, PD and safety profiles of LY01005 versus goserelin comparator to be conducted in the USA.
What is the current status of trial NCT03450109?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2017-12-22. Estimated completion is 2018-10-30.
What interventions are being tested in trial NCT03450109?
The interventions under investigation include: Zoladex (DRUG), LY01005 (DRUG).
Who is sponsoring clinical trial NCT03450109?
This trial is sponsored by Luye Pharma Group, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03450109's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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